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The US Food and Drug Administration (FDA) has historically developed mechanisms to expedite its review of innovative therapies. In December 2025, the agency outlined tenets of the plausible mechanism framework, intended to provide regulatory guidance when randomized controlled trials are not practical. It issued draft guidance on those tenets in February 2026. This article summarizes the FDA’s guidance on requirements for the approval of individualized therapies targeting specific conditions with known biological causes from an industry perspective.

This article discusses the current landscape of laboratory-developed tests (LDTs) following a federal court’s decision to vacate the FDA’s final rule, which represented the agency’s latest attempt to regulate this category of in vitro diagnostic (IVD) products. This article explores the history of the FDA’s efforts to regulate these tests, past and current enforcement trends, and best practices for developers and manufacturers to protect against compliance pitfalls.